Head and neck cancers (HNC) in India are a major health problem, constituting about one-third of all cancers (Shah et al., 2016). According to Global Cancer Incidence, Mortality, and Prevalence (GLOBOCAN), over 100,000 cases of oral malignancies are registered in India each year (Johnson and Amarasinghe, 2016; Bray et al., 2018). Main causes of HNC in India are chewing tobacco, smoking bidis and cigarettes, and alcohol consumption. Regardless of clinical advances in early diagnosis and treatment, HNCs result in significant functional, physical, and psychosocial effects and affect mortality rates (Gupta et al., 2016). Treatment toxicity is common and can lead to scarring, appearance changes or disfigurement, difficulties in talking, eating and swallowing, sticky saliva, weight loss, and dental problems (Semple et al., 2008). People treated for HNC most commonly report body image concerns from disfigurement and scarring. Studies have shown poorer body image in HNC patients post-surgery compared to before surgery (Hung et al., 2017) and that reduced body image is associated with a decline in general health-related quality of life (HRQoL) (Nayak et al., 2016; Manier et al., 2018).

Physical appearance and attractiveness are highly valued by individuals (Sharma et al., 2018) but influenced by various psychosocial factors such as personality, interpersonal factors (family and peers), and social factors (values and norms) (Sharma et al., 2018). Generally, when a person is diagnosed with a life-threatening disease such as cancer, they may initially perceive their physical appearance and body image as less important than concerns about survival (Page and Adler, 2008). Some individuals may continue to perceive disfigurement positively, reporting gratitude for being alive and surviving cancer, and self-confidence in dealing with body changes (Manier et al., 2018). While others may come to perceive disfigurement as an embarrassment resulting in social withdrawal, isolation, feelings of inadequacy, anxiety, and low self-esteem, all consequently contributing to poor HRQoL (Sundaram et al., 2019). Addressing body image issues may prevent these negative outcomes (Sharma et al., 2018). Therefore, in a population susceptible to disfigurement or appearance related changes, it is crucial to assess patient-reported outcomes (PROs) such as body image throughout the HNC disease and treatment journey to identify concerns and provide appropriate supportive care (Hopwood et al., 2001).

Many patient-reported outcome measures (PROMs) have been developed in English and are not suitable for use in countries where people do not speak English, or in immigrant populations or minority groups who also may not speak English (Guillemin et al., 1993; Saxena et al., 1998). Furthermore, with increased global immigration, an individual country can have inhabitants whose linguistic and cultural origins vary widely (Castles, 2000). With increasing transnational research involving multiple countries, including diverse patient groups in research is crucial as without adequate representation, the generalizability of study results to all segments of the population is questionable. There is potential for systematic bias in studies if whole sections of a population are excluded because they do not speak English or measures are not appropriate for them (Anderson et al., 1993; Beaton et al., 2000). Therefore, culturally relevant, valid, and reliable PRO measures are essential.

Translating existing valid and reliable patient-reported outcome measures (PROMs), rather than developing new ones, reduces effort, saves time, and speeds up the acquisition of knowledge related to cultural differences (Guillemin et al., 1993). To use a PROM across cultures, the items in the measure should be translated, their content validity and cultural appropriateness assessed (Sperber, 2004), and psychometric properties such as reliability, validity, and responsiveness tested. Such cross-cultural adaptation helps achieve equivalence between the original and translated versions of a measure (Guillemin et al., 1993).

India being a large, culturally diverse country, has an increasing number of clinical trials being conducted because of its potential to recruit large patient samples (Saxena et al., 1998; Gupta and Padhy, 2011). However, primary reasons reported for excluding Indian populations from participation in research are illiteracy and language barriers, with the main concern being lack of psychometrically robust PROs. Some PRO measures specific to HNC have been translated into few Indian languages and are cross culturally validated (Pandey et al., 2004; Thomas et al., 2004; Chaukar et al., 2005, 2009). For example, HNC-specific measures of quality of life developed by the European Organization for Research and treatment of Cancer Quality (e.g., EORTC QLQ-HN35) and the Functional Assessment of Cancer Therapy (FACT – Head and Neck) have been translated into several regional Indian languages (Chaukar et al., 2005). However, those assessing body image are not currently available in common Indian languages (Sundaram et al., 2019). Our earlier work found the Body Image Scale (BIS) to be the most appropriate measure for assessing body image in HNC populations following appraisal of its content and psychometric properties (Sundaram et al., 2019).

Our team recently translated the BIS into the Indian languages Tamil, Telugu, and Hindi, and demonstrated their cultural appropriateness and conceptual equivalence with the English original (Shunmugasundaram et al., 2021). The purpose of this study was to analyze the psychometric properties of the translated Indian versions of the BIS in HNC patients who speak Tamil, Telugu, and Hindi.

This study is a part of a larger study evaluating the psychometric properties of several translated PROMs assessing body image, unmet needs, anxiety, and depression in Indian HNC patients (Shunmugasundaram et al., 2020, 2021).

The incidence of HNCs is increasing in global regions such as India. Treatment for HNCs commonly leads to significant changes to appearance and negative effects to one’s body image. The BIS is a reliable and valid PROM for measuring body image in cancer patients. Studies have reported BIS has content appropriate to patients with breast cancer, HNC, colorectal cancer, and benign gynecological conditions (Brédart et al., 2007). However, it is a screening measure, that does not indicates a specific diagnosis related to body image disturbance. We recently translated the BIS into three common Indian languages (Shunmugasundaram et al., 2021). This study assessed the psychometric properties of the translated Indian versions of the BIS in a large sample of HNC patients.

The Tamil, Telugu, and Hindi versions of the BIS satisfy criteria for reliability and validity in line with recommended Food and Drug Administration guidelines for PRO instruments (Speight and Barendse, 2010). Thus, these translated versions can be used to assess body image in Indian HNC populations’ in future clinical research and in clinical practice.

In general, our findings are comparable with the original BIS validation results and other studies of language translations (Hopwood et al., 2001; Moreira et al., 2010; Karayurt et al., 2015). For construct validity of the Indian versions of the BIS, we found support for the factor structure (Hopwood et al., 2001; Karayurt et al., 2015). Kaiser’s criterion was used to determine the number of factors extracted. A one-factor solution for the BIS has emerged in both EFA and CFA, explaining 57.55, 61.8, and 68.11% of the total variance, respectively, consistent with other studies (Hopwood et al., 2001; Karayurt et al., 2015).

Our scaling findings were within acceptable criteria and convergent and discriminant validity was demonstrated from confirmed hypotheses about constructs expected to be related or unrelated. These findings are consistent with the original validation study, and also with the Portuguese and Turkish translation studies (Hopwood et al., 2001; Moreira et al., 2010; Karayurt et al., 2015). A BIS Portuguese validation study evaluated convergent validity and found moderate to high correlations between the Experience of Shame Scale’s body shame scale and Derriford Appearance Scale–24 consciousness of appearance scale with BIS (Moreira et al., 2010). In the same study, discriminant validity was supported by low correlations between BIS and WHOQOL (Physical, Environmental, General facet) scales (Moreira et al., 2010).

Reliability is the overall consistency of a PROM which can be calculated either by internal consistency of the items or test–retest reliability. High levels of internal consistency reliability provide greater confidence when using a measure to compare different groups (for example, those undergoing different treatments or those with different diagnoses). The reliability coefficients for all three Indian language versions were supported, with all Cronbach Alpha’s >0.89. These findings are consistent with those reported for the original BIS (0.93), Portuguese version (0.92–0.93), and Turkish version (0.94) (Moreira et al., 2010; Karayurt et al., 2015). These findings suggest the Indian versions of the BIS are equivalent with the original and other language translations in terms of content (Shunmugasundaram et al., 2021), reliability, and validity.

Data completeness was high for all three Indian language groups indicating there were no items to which a high proportion of participants did not respond. This is important as high levels of non-response can indicate problems with an item such as difficult to understand, or the measure contains distressing or irrelevant content. Generally, a total of <30% respondents selecting “not at all” or “very much” indicates an item does not show significant “floor” or “ceiling” effects, respectively. Analysis of response distributions showed all response categories were used for all items with no significant floor or ceiling effects in Telugu and Hindi populations. However, floor effects (32%) were found in the Tamil population. These results may be a reflection of the sample as only 50% of the Tamil samples were undergoing treatment, unlike Telugu (82%) or Hindi (94.5%) sample, and subsequently experiencing less impact on body image. Cognitive debriefing interviews conducted during the translation and linguistic validation phase with a diverse HNC patient population found the BIS was relevant, comprehensive, and unambiguous (Shunmugasundaram et al., 2021).

Our findings suggest Tamil speaking HNC population have fewer body image concerns than Telugu and Hindi speaking groups. Previous literature reports body image concerns were significantly higher among HNC patients with speech and eating concerns (Rhoten et al., 2013). Since, 81.9 and 94.5% of our Telugu and Hindi speaking groups were undergoing treatment, they may have been experiencing these concerns during their participation in the study. Studies have also found non-surgically treated patients with HNC have a better body image outcome than surgically treated patients (Rhoten et al., 2013; Ellis et al., 2019; Sundaram et al., 2019). Since 57.5% of the Hindi speaking population reported undergoing surgery for their HNC treatment, their body image dissatisfaction could be associated to visible disfigurement from surgery. Few studies have examined body image in Indian populations treated for HNC. Qualitative studies in the future should explore experiences of patients with HNC in India, with a focus on body image.

Body image is an important area of HRQoL research and about 75% of HNC patients treated surgically experience some level of bodily changes, often resulting in psychosocial challenges (Nayak et al., 2016). Although most common reactions to bodily changes are poorer body image and self-esteem and increased distress, self-consciousness and anxiety, some patients experience positive impacts such as regained confidence from their scars and view their scars as a reminder to be grateful for being alive and surviving cancer (Manier et al., 2018). India is a culturally diverse country and the floor effects in this study reflect that. Hence, it is possible that sample demographics and culture contribute to Tamil speaking participants low score on body image (low scores indicate no appearance related concerns).

Current globalization trends and the increasing importance of multinational clinical trials highlight the need for PROMs in languages other than English. PROMs developed in western countries may not be applicable to other cultures and require cross-cultural and linguistic validation. Although adapting a PROM for a different cultural group can be arduous and requires considerable investment of time and resources, unless this process is undertaken, the results of research using that PROM may be questionable. This is because language and culture have an impact on the way people respond to questions (Halliday and Hasan, 1989; Shunmugasundaram et al., 2021). If a non-English speaker answered a PROM in English, their responses may be biased or inaccurate, limiting the quality of the data. We need multilingual PROMs, suitable for routine clinical and research use, which are brief and inflict minimal patient burden to enable assessment of important outcomes and possibly improving study participation rates among ethnic groups in English speaking countries (Gupta and Padhy, 2011).

There is strong evidence that psychosocial interventions improve outcomes in cancer patients. However, for interventions to be effective, they need to be tailored to disease-specific outcomes. Using disease-specific measures will capture outcomes appropriately, particularly if they are translated and validated across languages and cultures. Assessing important outcomes could be used in clinical practice to help healthcare professionals identify concerns and address them directly. Although substantial efforts with regards to PROM development and validation have been made in the western literature to ensure robust measures are available, less has been studied and found available in the Indian literature (Saxena et al., 1998; Shah et al., 2016). This work serves as a model for ensuring future cultural relevance of measures for use in multinational trials.

This study had a number of strengths such as large samples across the three language groups, representative of different HNC types, disease stages and treatment phases, from multiple centers across India, and psychometric analyses to test the reliability and validity of the BIS according to internationally accepted standards. Future work will evaluate clinical validity (known groups) and responsiveness of the Indian versions of the BIS in longitudinal studies and the psychometric properties of the Tamil, Telugu, and Hindi versions of BIS among Indian immigrant populations with HNC living abroad. As India is a diverse country with a range of cultures and languages, more language translations or cross-cultural adaptations may be required to ensure inclusion of the entire Indian population in multinational trials.

The Tamil, Telugu, and Hindi versions of the BIS are valid and reliable measures of body image, with equivalent content and psychometrics as the original version as well as other language translations. The Indian BIS versions can be used in both clinical research and in healthcare settings to assess body image disturbances across HNC disease and treatments in Indian HNC patients in India and abroad.

This study formed part of CS’s PhD work.

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

Ethics approvals were obtained from the University of Sydney Human Research Ethics Committee (Sydney, Australia; Ref: 2019/202), Scientific Advisory Committee and Ethical Committee of Cancer Institute, WIA (Ref: IEC/2019/Sep 02), Ethical Committees of MNJ Institute of Oncology and Regional Cancer Centre (Regd No: ECR/Inst/AP/2013/RR-16 dated 18/04/2019; no reference number was provided in the letter of approval), and Nanavati Super Specialty Hospital. The patients/participants provided their written informed consent to participate in this study.

CS recruited participants and collected data (in one site) and supervised recruitment and data collection in the other sites, entered and managed data, checked for accuracy, analysed, and interpreted the findings, drafted, and wrote the manuscript. CR, HD, PB, and PS conceived the presented idea, developed the study design, helped plan the study and contributed to the preparation including ethics and data collection and supervised the overall study. MC, SV, NA, and NH contributed to ethics, recruitment, data collection, and discussed the results and contributed to the final manuscript. CR and HD verified the analytical methods and supervised the findings of this work. All authors contributed to the article and approved the submitted version.

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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